I.S. EN 15424:2007
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
Hardcopy , PDF
28-06-2011
English
01-01-2007
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Foreword
Introduction
1 Scope
1.1 Inclusions
1.2 Exclusions
2 Normative references
3 Terms and definitions
4 Quality Management System Elements
4.1 Documentation
4.2 Management responsibility
4.3 Product realization
4.4 Control of non-conforming product
5 Sterilizing agent characterization
5.1 General
5.2 Sterilizing agent
5.3 Microbicidal effectiveness
5.4 Material effects
5.5 Environmental considerations
6 Process and equipment characterization
6.1 General
6.2 Process
6.3 Equipment
7 Product definition
8 Process definition
9 Validation
9.1 General
9.2 Installation qualification
9.2.1 General
9.2.2 Installation
9.2.3 Equipment
9.3 Operational qualification
9.4 Performance qualification
9.4.1 General
9.4.2 Performance qualification - physical
9.4.3 Performance qualification - microbiological
9.4.4 Performance qualification - desorption and drying
9.5 Review and approval of validation
10 Routine monitoring and control
10.1 General
10.2 Biological indicators
10.3 Chemical indicators
10.4 Records
11 Product release from sterilization
12 Maintaining process effectiveness
12.1 General
12.2 Maintenance of equipment
12.3 Requalification
12.4 Assessment of change
Annex A (normative) Process definition based on inactivation of
reference microorganisms and knowledge of bioburden on
product items to be sterilized
A.1 General
A.2 Procedure
Annex B (normative) Process definition based on inactivation of
reference microorganisms
B.1 General
B.1.1 Overkill approach
B.1.2 Penetration characteristics into medical devices
B.2 Test procedure
B.2.1 General
B.2.2 Biological indicators
B.2.3 Test systems
B.2.4 Load configuration
B.2.5 Testing
Annex C (informative) Guidance on application of this European
Standard
C.1 Scope
C.2 Normative references
C.3 Terms and definitions
C.4 Quality management system elements
C.5 Sterilizing agent characterization
C.5.1 Neutralization
C.5.2 Studies of microbial inactivation
C.6 Process and equipment characterization
C.7 Product definition
C.7.1 General
C.7.2 Design considerations for medical devices intended
for sterilization
C.7.3 Packaging considerations
C.8 Process definition
C.8.1 General
C.8.2 Influence on product and packaging
C.8.3 Determination of process effectiveness
C.9 Validation
C.9.1 General
C.9.2 Installation qualification (IQ)
C.9.3 Operational qualification (OQ)
C.9.4 Performance qualification (PQ)
C.9.5 Documentation and approval of validation
C.10 Routine monitoring and control
C.11 Product release from sterilization
C.11.1 General
C.11.2 Product release using biological indicators
C.11.3 Parametric release
C.12 Maintaining process effectiveness
C.12.1 Change control
C.12.2 Requalification
Annex D (informative) Environmental aspects regarding development,
validation and control of Low Temperature Steam and
Formaldehyde processes
D.1 General
D.2 Formaldehyde (brief description)
D.3 Environmental impact of formaldehyde
D.4 Other environmental burdens
Annex ZA (informative) Relationship between this European Standard
and the Essential Requirements of EU Directive 93/42/EEC
Medical devices
Bibliography
Defines requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices.
| DocumentType |
Standard
|
| Pages |
48
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NF EN 15424 : 2007 | Identical |
| UNI EN 15424 : 2007 | Identical |
| SN EN 15424 : 2007 | Identical |
| UNE-EN 15424:2007 | Identical |
| EN 15424:2007 | Identical |
| NS EN 15424 : 1ED 2007 | Identical |
| NEN EN 15424 : 2007 | Identical |
| NBN EN 15424 : 2007 | Identical |
| BS EN 15424:2007 | Identical |
| DIN EN 15424:2007-08 | Identical |
| EN ISO 11737-2:2009 | Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009) |
| IEC 61010-2-040:2015 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials |
| EN ISO 14937:2009 | Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) |
| EN 61010-2-040:2015 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040 Particular requirements for sterilizers and washer-disinfectors used to treat medical materials |
| EN ISO 11140-3:2009 | Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007) |
| ISO 11737-2:2009 | Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| ISO 11737-1:2006 | Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
| EN ISO 10993-17:2009 | Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| EN ISO 14161:2009 | Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009) |
| EN 867-5:2001 | Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S |
| EN 14180:2014 | Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing |
| EN ISO 11138-1:2017 | Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017) |
| EN ISO 11140-1:2014 | Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) |
| ISO/TS 11139:2006 | Sterilization of health care products Vocabulary |
| AAMI RD47 : 2008 | REPROCESSING OF HEMODIALYZERS |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 10012:2003 | Measurement management systems — Requirements for measurement processes and measuring equipment |
| EN ISO 11140-4:2007 | Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007) |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
| CEN Guide 4:2008 | GUIDE FOR ADDRESSING ENVIRONMENTAL ISSUES IN PRODUCT STANDARDS |
| EN ISO 10012:2003 | Measurement management systems - Requirements for measurement processes and measuring equipment (ISO 10012:2003) |
| ISO 14161:2009 | Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
| ISO 11138-5:2017 | Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
| EN ISO 11138-5:2017 | Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017) |
| EN ISO 9000:2015 | Quality management systems - Fundamentals and vocabulary (ISO 9000:2015) |
| 1997/23/EC : 1997 | DIRECTIVE 97/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 29 MAY 1997 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES CONCERNING PRESSURE EQUIPMENT |
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